Dataset Information

A Comparative Study of A Novel Postural Garment Versus Exercise for Women with Nonspecific Cervical Pain: A Randomized Cross-Over Trial.

ABSTRACT:

Study design

Randomized crossover study.

Objective

To compare exercise, the gold standard, to the postural garment PosturePlusForce® in the management of nonspecific cervical pain in women. We also analyzed both interventions with regards to baseline posture, use of pharmacological pain relievers, compliance, and comfort.

Summary of background data

The prevalence of neck pain has increased during the last decade, preferentially affecting women. Those suffering from this condition may manifest a decrease in quality of life and inability to work. Consistent recommendations highlight the importance of exercise and posture for neck pain improvement.

Methods

A total of 32 female healthcare professionals with cervical pain (≥3 on the visual analogue scale) entered the trial. Participants were allocated to either performing exercises or wearing the postural garment. The crossover between interventions was separated by a 3-month washout period. Primary outcomes included pain intensity and posture. Secondary outcomes comprised cervical pain-related disability, psychological factors, physical activity, global perceived effect of treatment, and garment comfort. Treatment compliance, medication use, and adverse events were also recorded.

Results

Both interventions showed a significant improvement in pain in subjects with an adherence >60%. However, in participants with dorsal hyperkyphosis (>45°), the garment demonstrated a greater reduction in pain than exercise (p = 0.019). Additionally, those wearing the garment needed fewer pain relievers than those performing exercises (p = 0.007). Compliance was above 50% for both interventions and comfort was contingent on season.

Conclusions

In our study, PosturePlusForce® showed, at least, a similar effect on pain to exercise, although those with dorsal hyperkyphosis exhibited a greater reduction in pain and related variables with the garment. Pain relievers were less required by those wearing PosturePlusForce® than by those performing the exercises.Level of Evidence: 1.

SUBMITTER: Avellanet M

PROVIDER: S-EPMC8553007 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:There is a high prevalence of work-related musculoskeletal disorders among health care professionals. Posture is an essential point to be addressed for health care professionals with musculoskeletal disorders. Cervical pain can result from several conditions. Treatment should include posture modification and home exercise. OBJECTIVE:This study aims to compare a new postural garment (Posture Plus Force; Medi, Bayreuth, Germany) with exercises for women with nonspecific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work-related musculoskeletal disorders. METHODS:This randomized crossover clinical trial has a 3-month treatment sequence and a 3-month washout period. Participants will include nurses and allied health professionals 21 to 55 years of age with cervical pain. Participants are allocated at random to two intervention groups: a postural garment (Posture Plus Force) to be worn for 2 to 4 hours per day for 90 days (P+ group) and five physiotherapy sessions (20 minutes each) to learn stretching and strengthening exercises with instructions to continue at home on a daily basis for 90 days (Ex group). The participants in each group will crossover interventions after a 3-month washout period. The primary outcomes are postural control and pain intensity. A static posturography will be performed with a scan (SpinalMouse; Idiag AG, Fehraltorf, Switzerland). The visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual participants. The secondary outcomes are cervical pain-related disability, catastrophizing, the global perceived effect of treatment, and the evaluation of garment comfort. Physical activity is assessed with the International Physical Activity Questionnaire. Assessment of primary and secondary outcomes is performed at T0 (pre-intervention), T1 (immediately after garment fitting for P+ group), T30, T60, and T90. The same measurements are recorded after the washout period and during the second intervention following the same sequence. All patients are provided with a logbook for compliance recording, over the counter drug use, pain evaluation, and sick leave. Statistical analysis is conducted following intention-to-treat principles and the treatment effects calculated using linear mixed models. RESULTS:The study design has been approved by the Ethics Commission of Hospital N Sra de Meritxell, Andorra in March 2017. A total of 32 participants are already enrolled in the study. An extension of the study is planned in a Spanish university hospital to achieve a larger sample. Study results are expected to be published during 2020. CONCLUSIONS:The Postural garment is expected to improve cervical pain by enhancing posture. TRIAL REGISTRATION:ClinicalTrials.gov NCT03560492; https://clinicaltrials.gov/ct2/show/NCT03560492. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14807.

Project description:BackgroundPhysical exercise is a common treatment for people with low back pain (LBP). Wearable sensors that provide feedback on body movements and posture during exercise may enhance postural balance and motor control in people with LBP.ObjectiveThis study aims to investigate whether physical exercising with postural feedback (EPF) improves postural balance, motor control, and patient-reported outcomes in people with LBP.MethodsThe study was an assessor-blinded 2×2 factorial trial. We planned to recruit 80 participants with nonspecific LBP who did not receive treatment for LBP. In addition, we aimed to recruit 40 patients with chronic, nonspecific LBP who were receiving exercise therapy (ET) at the University Hospital Zurich. Both ET patients and participants without treatment were randomized to receive either an additional EPF intervention or no additional intervention. This resulted in four different combinations of interventions: ET+EPF, ET, EPF, and no intervention. The participants underwent outcome assessments at inclusion (T1); 3 weeks later, at randomization (T2); after an intervention period of 3 weeks with a predefined exercise schedule for participants receiving EPF (T3); and after an additional 6 weeks, during which participants assigned to the EPF groups could exercise as much as they wished (T4). Patients receiving ET completed their regularly prescribed therapies during the study period. Balance was assessed during quiet standing on a force platform, and motor control was assessed during a lifting task and a waiter's bow task. Physical activity was recorded using an activity tracker and the participants' mobile phones during the study. The predefined EPF schedule consisted of nine sessions of 20 minutes of exercise with a tablet and inertial measurement unit sensors at home. Participants performed a series of trunk and hip movements and received feedback on their movements in a gamified environment displayed on the tablet.ResultsThe first participant was recruited in May 2019. Data collection was completed in October 2020, with 3 patients and 32 eligible people without therapy who passed the eligibility check.ConclusionsAlthough it will not be possible to investigate differences in patients and people without other therapies, we expect this pilot study to provide insights into the potential of EPF to improve balance in people with LBP and adherence to such interventions.International registered report identifier (irrid)DERR1-10.2196/26982.

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Project description:Sensorimotor training (SMT) is popularly applied as exercise in rehabilitation settings, particularly for musculoskeletal pain. With insufficient evidence on its effect on pain and function, this exploratory randomised controlled trial investigated the potential effects of SMT in rehabilitation of chronic non-specific low back pain. Two arms received 9x30 minutes physiotherapy with added interventions: The experimental arm received 15 minutes of postural SMT while the comparator arm performed 15 minutes of added sub-effective low-intensity training. A treatment blinded tester assessed outcomes at baseline 2-4 days prior to intervention, pre- and post-intervention, and at 4-week follow-up. Main outcomes were pain and functional status assessed with a 0-100mm visual analogue scale and the Oswestry Disability Questionnaire. Additionally, postural control was analysed using a video-based tracking system and a pressure plate during perturbed stance. Robust, nonparametric multivariate hypothesis testing was performed. 22 patients (11 females, aged 32 to 75 years) with mild to moderate chronic pain and functional limitations were included for analysis (11 per arm). At post-intervention, average values of primary outcomes improved slightly, but not to a clinically relevant or statistically significant extent. At 4-week follow-up, there was a significant improvement by 12 percentage points (pp) on the functional status questionnaire in the SMT-group (95% confidence intervall (CI) = 5.3pp to 17.7pp, p < 0.001) but not in the control group (4 pp improvement, CI = 11.8pp to 19.2pp). However, group-by-time interaction effects for functional status (Q = 3.3, 19 p = 0.07) and pain (Q = 0.84, p = 0.51) were non-significant. Secondary kinematic outcomes did not change over time in either of the groups. Despite significant improvement of functional status after SMT, overall findings of this exploratory study suggest that SMT provides no added benefit for pain reduction or functional improvement in patients with moderate chronic non-specific low back pain.Trial registrationClinicalTrials.gov NCT02304120 and related study protocol, DOI: 10.1186/1471-2474-15-382.

Project description:BACKGROUND:According to the American Physical Therapy Association, there is strong evidence to show that vertebral mobilization and manipulation procedures can be used to improve spinal and hip mobility and reduce pain and incapacity in low back pain patients that fit the clinical prediction rule. OBJECTIVES:To evaluate the immediate effects of high-velocity low-amplitude (HVLA) manipulation on pain and postural control parameters in individuals with nonspecific low back pain. METHODS:This study used a participant-blinded and assessor-blinded randomized controlled clinical trial involving a single session, in which 24 participants were randomly distributed into control (simulated manipulation) and intervention (HVLA lumbar manipulation) groups. The primary (pain: subjective pain intensity and pressure pain threshold) and secondary outcomes (postural control: ellipse area, center of pressure [COP] excursion, COP RMS velocity, and differences between the COP and center of projected gravity) were evaluated before and after the session using a numerical pain scale, algometer, and a force platform. For all outcomes, multiple mixed 2 (group) × 2 (time) ANOVAs were performed. RESULTS:For the subjective pain intensity, only time was significant as a main effect, where pre-intervention presented a greater value then post-intervention (F [1.44]?=?4.377; p =?0.042; r =?0.30). For the pressure pain threshold no significant effect was found. For the postural control parameters, as a main effect, only the ellipse area was significantly greater in the control group (F [1.44]?=?6.760; p =?0.013; effect size?=?0.36). CONCLUSIONS:There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure. No effect of HVLA lumbar manipulation was identified for postural control variables in either the intervention or control groups. TRIAL REGISTRATION:The study was registered at ClinicalTrials.gov under the number NCT02312778, registered at 14 September 2014.